fyremadel

Generic: ganirelix acetate

Labeler: ferring pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fyremadel
Generic Name ganirelix acetate
Labeler ferring pharmaceuticals inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

ganirelix acetate 250 ug/.5mL

Manufacturer
Ferring Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 55566-1010
Product ID 55566-1010_5b000831-15ef-44ff-9fce-3a2289d5e047
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204246
Listing Expiration 2026-12-31
Marketing Start 2022-02-28

Pharmacologic Class

Classes
decreased gnrh secretion [pe] gonadotropin releasing hormone receptor antagonist [epc] gonadotropin releasing hormone receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 555661010
Hyphenated Format 55566-1010

Supplemental Identifiers

RxCUI
855200 2587594
UNII
56U7906FQW

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name fyremadel (source: ndc)
Generic Name ganirelix acetate (source: ndc)
Application Number ANDA204246 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 250 ug/.5mL
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (55566-1010-1) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE
source: ndc

Packages (1)

55566-1010-1 1 BLISTER PACK in 1 CARTON (55566-1010-1) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE

Ingredients (1)

ganirelix acetate (250 ug/.5mL)

Linked Drug Pages (1)

Fyremadel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "5b000831-15ef-44ff-9fce-3a2289d5e047", "openfda": {"unii": ["56U7906FQW"], "rxcui": ["855200", "2587594"], "spl_set_id": ["5f0908b5-3551-47fd-95f7-3669b0dff7f1"], "manufacturer_name": ["Ferring Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (55566-1010-1)  / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE", "package_ndc": "55566-1010-1", "marketing_start_date": "20220228"}], "brand_name": "Fyremadel", "product_id": "55566-1010_5b000831-15ef-44ff-9fce-3a2289d5e047", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Decreased GnRH Secretion [PE]", "Gonadotropin Releasing Hormone Receptor Antagonist [EPC]", "Gonadotropin Releasing Hormone Receptor Antagonists [MoA]"], "product_ndc": "55566-1010", "generic_name": "ganirelix acetate", "labeler_name": "Ferring Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fyremadel", "active_ingredients": [{"name": "GANIRELIX ACETATE", "strength": "250 ug/.5mL"}], "application_number": "ANDA204246", "marketing_category": "ANDA", "marketing_start_date": "20220228", "listing_expiration_date": "20261231"}